Th The Im Importance of Contin inued Rese search Train inin ing - - PowerPoint PPT Presentation

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Th The Im Importance of Contin inued Rese search Train inin ing - - PowerPoint PPT Presentation

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Th The Im Importance of Contin inued Rese search Train inin ing & Avail ilable le Reso sources at t Jo Johns Hopkin ins Regulatory Changes in Clinical Research 2016 Changes to the electronic data submission for New Drug

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Th The Im Importance of Contin inued Rese search Train inin ing & Avail ilable le Reso sources at t Jo Johns Hopkin ins

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Regulatory Changes in Clinical Research

  • 2016

– Changes to the electronic data submission for New Drug Applications, Abbreviated New Drug Applications, Biologics License Applications, and Investigational New Drug Applications

  • 2017

– Good Clinical Practice (GCP) Training required for all NIH funded Clinical Trials. – Expansion of Federal requirements to register clinical trials at ClinicalTrials.gov

  • 2019

– Effective Jan 21, 2019 all new federally funded human subjects research studies must comply with the revised Common Rule. (Expansion of the number of Exempt categories, new Key elements section in the Informed Consent, and changing of continuing review requirements) – Coming in 2020 Requirement to use a single IRB

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Competencies

  • 2014 the Joint Task Force (JTF) published

Harmonized Core Competency Framework for the Clinical Research Professional

  • Clinical research institutions worldwide have

adapted the framework to develop job descriptions, training modules, and other resources

  • 2017 Version 2.0 of the Competency Framework

was released

https://www.clinicaltrialcompetency.org/

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Differences Between Children and Adults as Learners

Children

  • Rely on others to decide what

is important to be learned.

  • Accept the information being

presented at face value.

  • Expect what they are learning

to be useful in their long-term future

  • Have little or no experience

upon which to draw – are relatively “clean slates.”

  • Little ability to serve as a

knowledgeable resource to teacher or fellow classmates Adults

  • Decide for themselves what is

important to be learned

  • Need to validate the

information based on their beliefs and experience.

  • Expect what they are learning

to be immediately useful.

  • Have much experience upon

which to draw – may have fixed viewpoints.

  • Significant ability to serve as a

knowledgeable resource to trainer and fellow learners

https://www.pacer.org/publications/fasttraining/Other/teaching adults-whattrainersneedtoknow.pdf

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Percent of Adult Recall in the Learning Process

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Adult Learners

  • Interactive
  • Immediately Applicable
  • Multi level Engagement
  • Ability to Apply past and recently gain knowledge
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Certifications

ACRP Association of Clinical Research Professionals

  • 4 exam types – Clinical Research

Associate, Clinical Research Coordinator, Principle Investigator, ACRP Certified Professional

  • Computer Based testing (twice

annually)

  • Membership Fees: $150 per year
  • Certification Costs: $435/$460
  • Length of Certification: 2 years
  • Certification Maintenance:

Continuing Education, Continuing Involvement, and Recert cost $225/$250/$325 SoCRA The Society of Clinical Research Associates

  • 1 exam type – Clinical Research

Professional

  • Paper and Computer Based testing
  • Membership Fees: $75 per year
  • Certification Costs:$395 (additional

$115 for CBT)

  • Length of Certification: 3 years
  • Certification Maintenance:

Continuing Education and Recert cost $350 must complete learning module

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Johns Hopkins Training

  • JH School of Nursing Professional Programs

– Research Coordinator Training Course – First Friday Lectures

  • My Learning

– Training online and in person in a variety of topics – IRB training, Biohazard Training, DOT/IATA training – https://lms14.learnshare.com/dashboard/dash.home.aspx?Z =303XUdNOjuqsElviRmjQiH2j1gxo%2fxRKWAlF%2fU%2b0Z0o %3d&LSMID=

  • Coursera

– https://www.coursera.org/programs/coursera-for-johns- hopkins-university-zfk78?authProvider=jhu

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JH School of Nursing Professional Programs

  • Research Coordinator Training Program (RCTP)

– May 8-10 2019 – Cost $1900 (Professional Development Dollars) – https://learn.nursing.jhu.edu/face-to- face/courses/research-coordinator/index.html

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My Learning

  • Required Training
  • Any courses that have fees are covered by

Professional Development

  • History Log of all training online
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My Learning

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Coursera

  • Online Course taught by Instructors for Universities

and Educational Institutes Worldwide

  • Free Course – Some Paid Certificate and Degree

Programs

  • Mobile Access
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Coursera

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ICTR Resources

https://ictr.johnshopkins.edu/study_team/training-education/

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The Science of Clinical Investigations (SOCI)

  • https://www.jhsph.edu/academics/graduate-training-

programs-in-clinical-investigation/advanced- training/online-soci-training-program.html

  • 390.678.81 Quality Improvement and Knowledge

Translation (First Term)

  • 390.673.81 Ethical and Regulatory Issues in Clinical

Research (Second Term)

  • 390.676.81 Design of Clinical Studies (Third Term
  • 390.672.81 Quantitative Analysis of Clinical Data

(Fourth Term)

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Tuition Remission

http://benefits.jhu.edu/tuition/remission.cfm

  • You are eligible for tuition remission once you have

completed 120 days of full-time employment as long as you are JHU faculty, staff or a retiree.

  • Visiting faculty and staff, residents, interns and post-

doctoral fellows are not eligible for tuition remission

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Tuition Remission

http://benefits.jhu.edu/tuition/remission.cfm

  • Part-time credit and non-credit courses offered through the

continuing education unit of one of JHU’s academic divisions are covered under this plan.

  • Outside courses, conferences, and seminars may also be

covered if required for the employee to maintain a job- required professional certificate or license regulated by the State Licensing Board.

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Tuition Remission

http://benefits.jhu.edu/tuition/remission.cfm

  • There is a $5,250 annual family limit on tuition

remission for faculty, staff, retirees

  • You are responsible for any spending that exceeds

the limits, and for tuition costs for courses not completed (i.e., withdrawn or dropped).

  • Faculty, staff, and retirees are eligible for 100%

remission for credit courses, and 25% remission for private credit instruction at Peabody.

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Tuition Remission – Professional Development

  • http://benefits.jhu.edu/tuition/remission.cfm
  • There is no annual dollar limit or reduction of

annual limits for non-credit professional development or personal enrichment courses.

  • You receive 100% remission if your department

certifies the course is valuable for your professional development and your department is willing to pay if you do not attend or cancel from the course with at least one week's notice.

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Upcoming Events

Tuesday, January 22, 1:00 p.m.-2:30 p.m. 2024 East Monument Street, 1-500Q Readying the R: Gail L. Daumit, MD, MHS, FACP, Samsung Professor of Medicine, General Internal Medicine, Psychiatry and Behavioral Sciences, Epidemiology, Health Policy and Management and Mental Health; Research Director, Division of General Internal Medicine; Co-Chair, Institutional Review Board X; Elise Weerts, PhD, Professor, Department of Psychiatry and Behavioral Sciences Click here to register